Pilot Study of Casdatifan-Treated Refractory Renal Cell Carcinoma (NCT07748988) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Pilot Study of Casdatifan-Treated Refractory Renal Cell Carcinoma
United States12 participantsStarted 2029-07-01
Plain-language summary
This is a single-institution, pilot study of oral casdatifan, a selective HIF-2α inhibitor, in patients with metastatic clear cell renal cell carcinoma refractory to prior IO- and VEGF-based therapies. The study will assess changes in HIF2-regulated gene expression through RNA sequencing of serial tumor biopsies obtained at baseline, during treatment, and at progression. Blood samples will also be collected for future analyses.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed and dated written informed consent.
. Male or female ≥ 18 years of age on the day of signing informed consent.
. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
. Patients must have received at least one immune oncology (IO) agent and at least one VEGF-targeted therapy (alone or in combination)
. Measurable tumor burden which can be followed by computed tomography (CT) scan or magnetic resonance imaging (MRI), based on RECIST 1.1 as assessed by the local site investigator
. At least one metastatic lesion that is amenable to percutaneous biopsy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To determine the change in expression of predefined HIF2-regulated target genes in metastatic tumor tissue following casdatifan therapy in a refractory ccRCC population.
. Adequate organ and bone marrow function resulted ≤ 28 days prior to first dose of protocol-indicated treatment:
Exclusion criteria
. Prior treatment with HIF 2α inhibitors (e.g. belzutifan or related agents)
. Is currently participating in or within 2 weeks prior to receiving first dose of study treatment in a study of an investigational agent or investigational device.
. Known severe hypersensitivity (≥ Grade 3) to any of the excipients of casdatifan.
. History of myocarditis or pericarditis or other known underlying heart disease that is clinically significant by investigator judgment (for example, cardiomyopathy, congestive heart failure with New York Heart Association \[NYHA\] functional classification III or IV, symptomatic arrhythmia not controlled by medication, unstable angina, history of acute myocardial infarction). History of cerebrovascular accident (including TIA) within the past 6 months (24 weeks) prior to starting study treatment.
. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection/sepsis, interstitial lung disease, recent hospitalizations with unresolved symptoms, poorly controlled hypertension, or psychiatric illness/social situations that would limit compliance with study requirements.
. Inability to swallow study treatment.
. Contraindications to biopsy (e.g. bleeding diathesis, uncorrectable coagulopathy)